NCT00988663

Brief Summary

The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

Same day

First QC Date

October 1, 2009

Last Update Submit

March 21, 2017

Conditions

Major Depressive Disorder

Keywords

electroconvulsive therapymemantinecognitive functionmemory

Outcome Measures

Primary Outcomes (1)

  • Assessment of whether Memantine protects memory and cognitive impairment caused by ECT.

    6 to 8 weeks

Secondary Outcomes (1)

  • Whether memantine will improve response of Depression to Electroconvulsive therapy.

    6-8 weeks

Study Arms (2)

Memantine arm

ACTIVE COMPARATOR

Patient receiving ECT and Memantine

Drug: memantine

placebo

PLACEBO COMPARATOR

25 patients receiving ECT will will receive placebo

Drug: memantineDrug: Placebo

Interventions

memantineDRUG

patient will receive 5mg daily for 7day then 10 mgm daily

Also known as: Namenda
Memantine armplacebo
PlaceboDRUG

will give placebo that looks like memantine

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for Major Depressive disorder

You may not qualify if:

  • Neurological disease
  • Mental retardation
  • Seizure disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa hosptitals and clinic

Iowa City, Iowa, 50208, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Memantine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jerry L Lewis, MD

    University of Iowa Hospitals and Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

US(1)